Job Summary
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We are seeking a skilled Associate to join our team. As an Associate, you will play a crucial role in ensuring the management of essential documents in compliance with regulatory requirements.
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* You will be responsible for processing and reviewing rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* You will perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* You will work with Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* You will communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
* You will escalate any TMF Quality issues in a timely manner to the RMC Lead.
* You will provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
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Responsibilities
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